Theca Cell Function in Adolescents With Polycystic Ovary Syndrome (PCOS)
1 other identifier
interventional
24
1 country
1
Brief Summary
In women with polycystic ovary syndrome (PCOS), the cardinal physiological abnormality is excessive ovarian androgen production marked by increased serum testosterone (T) and androstenedione (A) levels. Studies to determine the alteration in ovarian steroidogenesis that lead to abnormal production of ovarian androgens have revealed increased CYP17 gene expression with accentuated 17-hydroxylase activity leading to exaggerated 17-hydroxyprogesterone (17P) responses to luteinizing hormone (LH) stimulation. In contrast, T and A responses did not distinguish between PCOS and normal women, although these androgens were clearly greater in the former compared to the latter group. As a result, 17P responsiveness has been employed to determine the functional capacity of the ovary to produce androgens. The stimulatory agents that have been used included GnRH agonist, Lupron, at a dose of 10 microgram per kilogram, or hCG at a dose of 10,000 IU. The investigators propose to conduct a study that will determine the pattern of androgen responsiveness to 25ucg of hCG after 24 hours in adolescents with PCOS, those with oligomenorrhea, and in normal controls. This will allow for a comparison of these adolescents' ovarian functional capacity to produce androgens.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2010
CompletedFirst Posted
Study publicly available on registry
June 30, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
April 23, 2019
CompletedApril 30, 2019
April 1, 2019
2.9 years
June 29, 2010
March 29, 2019
April 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
17OHP Levels After hCG
Assess serum levels of 17OHP after stimulation with recombinant hCG
24 hours
Secondary Outcomes (3)
Testosterone
24 hours
Androstenedione
24 hours
DHEA
24 hours
Study Arms (3)
PCOS group
EXPERIMENTALIntervention: Each subject in the PCOS group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Normal group
EXPERIMENTALIntervention: Each subject in the Normal group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.
Oligomenorrhea group
EXPERIMENTALIntervention: Each subject in the Oligomenorrhea group will receive dexamethasone 1 mg orally in the evening and return the next morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will the have blood drawn at -0.5, 0, 0.5, and 24 hours after hCG injection for steroid hormone measurements.
Interventions
Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
Eligibility Criteria
You may qualify if:
- Normal CBC (Hemoglobin must be at least 11mg/dl)
- Normal renal and liver function tests
- Normal vital signs including normal blood pressure
You may not qualify if:
- Pregnancy
- On oral contraceptives
- On insulin lowering drugs
- On anti-androgens (i.e., spironolactone, flutamide, finasteride, etc)
- On medications that will influence androgen metabolism or clearance
- On medications that will inhibit the cytochrome P450 enzyme system (Cimetidine, ketoconazole, etc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- University of Virginiacollaborator
Study Sites (1)
UCSD School of Medicine
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. R. Jeffrey Chang
- Organization
- UC San Diego School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
R. Jeffery Chang, M.D.
UCSD School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 29, 2010
First Posted
June 30, 2010
Study Start
August 1, 2011
Primary Completion
July 1, 2014
Study Completion
September 1, 2014
Last Updated
April 30, 2019
Results First Posted
April 23, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share